Quick answers
- What is Ethacrynic acid used for?
- The FDA-approved label (Edecrin, Bausch Health US, LLC, August 31, 2020) says: “EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ethacrynic acid have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ethacrynic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ethacrynic acid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ethacrynic acid?
- 10 companies list prescription products of Ethacrynic acid in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC and Edenbridge Pharmaceuticals LLC..
What Ethacrynic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. …
— FDA label: Edecrin, Bausch Health US, LLC, effective August 31, 2020. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Edecrin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethacrynic acid 25 mg tablet | Generic | $0.8221 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Lupin Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals NY LLC1 product
- Edenbridge Pharmaceuticals LLC.1 product
- ScieGen Pharmaceuticals, Inc.1 product
- TruPharma, LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- St. Mary's Medical Park Pharmacy1 product
- Oceanside Pharmaceuticals1 product
- Bryant Ranch Prepack1 product
- Bausch Health US, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016092 EDECRIN | Bausch | January 10, 1967 | 31, latest March 30, 2015 2015: Manufacturing (CMC) · 2005: Labeling · 2004: Labeling |
Generic approvals (6)
- ANDA205609Adaptis · June 30, 2016
- ANDA208805Amneal Pharms Co · May 8, 2018
- ANDA211809Agnitio · July 12, 2019
- ANDA211232Sciegen Pharms · August 27, 2019
- ANDA211719Lupin · September 6, 2019
- ANDA212417Upsher Smith Labs · February 19, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 211509, 617325, 1251903, 1251905 |
|---|---|
| SPL set ID of the quoted label | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 |
| FDA labels (SPL) | 10 |
| FDA applications | NDA016092, 6 ANDA |
| Active ingredients (FDA) | ETHACRYNIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Edecrin, Bausch Health US, LLC, effective August 31, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →